Stability of Patient Social Determinants of Health With a Focus on Food Insecurity.

Introduction/objectives: Many health systems screen patients for social determinants of health and refer patients with social needs to community service organizations for assistance. However, few studies have examined how social determinants of health change over time in the same individuals.

Methods: We examined patients screened by The MetroHealth System in Cleveland, Ohio for 11 social determinants of health, including food insecurity, financial strain, transportation, housing stability, utilities affordability, other housing problems, intimate partner violence, social connection, physical activity, daily stress, and digital connectivity.

A Randomized Trial to Address Food Insecurity and Promote Smoking Cessation Among Low-Income Adults.

Many low-income adults who smoke also have unmet social needs, such as food insecurity, which can serve as a barrier to smoking cessation. We developed a novel intervention to jointly address smoking cessation and food insecurity and assessed its feasibility, acceptability, and preliminary outcomes. We enrolled participants who screened for food insecurity, reported smoking daily, and were ready to quit.

Food as Medicine Clinic: Early Results and Lessons Learned.

Introduction: Hospital-based food pantries are commonly used to address food insecurity. However, few studies have examined the impact of these food pantries on patients with chronic health conditions. In this study, we sought to assess the effect of a hospital-based food pantry clinic on self-reported dietary changes, health outcomes, and resource utilization.

Food insecurity, social needs, and smoking status among patients in a county hospital system.

Tobacco use in the U.S. is increasingly concentrated among populations with socioeconomic disadvantages such as food insecurity.

Clustering of Social Determinants of Health Among Patients.

Introduction/objectives: Many health systems screen patients for social determinants of health and refer patients with social needs to community organizations for assistance. Understanding how social determinants cluster together may help guide assistance programs.

Methods: This study examined patients screened by The MetroHealth System in Cleveland, Ohio for 9 social determinants, including food insecurity, financial strain, transportation limitations, inability to pay for housing or utilities, intimate partner violence, social isolation, infrequent physical activity, daily stress, and lack of internet access.

A Framework for Evaluating Social Determinants of Health Screening and Referrals for Assistance.

Introduction/objectives: Many health systems screen patients for social determinants of health and refer patients with social needs to community service organizations for assistance. We developed a framework based on sequential steps to evaluate this process.

Methods: We reviewed efforts by The MetroHealth System in Cleveland, Ohio and identified 6 sequential steps: patient screened, has social needs, consents to referral to a service organization, referral placed, referral accepted, and referral outcome.

Systemic and local immunity following adoptive transfer of NY-ESO-1 SPEAR T cells in synovial sarcoma.

Background: Gene-modified autologous T cells expressing NY-ESO-1, an affinity-enhanced T-cell receptor (TCR) reactive against the NY-ESO-1-specific HLA-A*02-restricted peptide SLLMWITQC (NY-ESO-1 SPEAR T-cells; GSK 794), have demonstrated clinical activity in patients with advanced synovial sarcoma (SS). The factors contributing to gene-modified T-cell expansion and the changes within the tumor microenvironment (TME) following T-cell infusion remain unclear. These studies address the immunological mechanisms of response and resistance in patients with SS treated with NY-ESO-1 SPEAR T-cells.

Long-term safety and activity of NY-ESO-1 SPEAR T cells after autologous stem cell transplant for myeloma.

This study in patients with relapsed, refractory, or high-risk multiple myeloma (MM) evaluated the safety and activity of autologous T cells engineered to express an affinity-enhanced T-cell receptor (TCR) that recognizes a peptide shared by cancer antigens New York esophageal squamous cell carcinoma-1 (NY-ESO-1) and L-antigen family member 1 (LAGE-1) and presented by HLA-A*02:01. T cells collected from 25 HLA-A*02:01-positive patients with MM expressing NY-ESO-1 and/or LAGE-1 were activated, transduced with self-inactivating lentiviral vector encoding the NY-ESO-1TCR, and expanded in culture. After myeloablation and autologous stem cell transplant (ASCT), all 25 patients received an infusion of up to 1 × 10 NY-ESO-1 specific peptide enhanced affinity receptor (SPEAR) T cells.

Predicting seizure freedom after epilepsy surgery, a challenge in clinical practice.

Objective: The objective of this study was to compare the accuracy of clinical judgment in predicting seizure outcome after resective epilepsy surgery relative to two recently published statistical tools [the Epilepsy Surgery Nomogram (ESN) and the modified Seizure-Freedom score (m-SFS)].

Methods: Details of presurgical evaluations of 20 patients who underwent epilepsy surgery were presented to 20 epilepsy experts. The final surgical treatment was also disclosed.

Models for Predicting Recurrence, Complications, and Health Status in Women After Pelvic Organ Prolapse Surgery.

Objective: To develop statistical models predicting recurrent pelvic organ prolapse, surgical complications, and change in health status 12 months after apical prolapse surgery.

Methods: Logistic regression models were developed using a combined cohort from three randomized trials and two prospective cohort studies from 1,301 participants enrolled in surgical studies conducted by the Pelvic Floor Disorders Network. Composite recurrent prolapse was defined as prolapse beyond the hymen; the presence of bothersome bulge symptoms; or prolapse reoperation or retreatment within 12 months after surgery.

Antitumor Activity Associated with Prolonged Persistence of Adoptively Transferred NY-ESO-1 T Cells in Synovial Sarcoma.

We evaluated the safety and activity of autologous T cells expressing NY-ESO-1, an affinity-enhanced T-cell receptor (TCR) recognizing an HLA-A2-restricted NY-ESO-1/LAGE1a-derived peptide, in patients with metastatic synovial sarcoma (NY-ESO-1T cells). Confirmed antitumor responses occurred in 50% of patients (6/12) and were characterized by tumor shrinkage over several months. Circulating NY-ESO-1T cells were present postinfusion in all patients and persisted for at least 6 months in all responders.

External validation of the TIMI risk score for secondary cardiovascular events among patients with recent myocardial infarction.

Background And Aims: Risk stratification of patients with recent myocardial infarction (MI) for subsequent cardiovascular (CV) events helps identify patients most likely to benefit from secondary prevention therapies. This study externally validated a new risk score (TRS2˚P) for secondary events derived from the TRA2°P-TIMI 50 trial among post-MI patients from two large health care systems.

Methods: This retrospective cohort study included 9618 patients treated for acute MI at either the Cleveland Clinic (CC) or Geisinger Health System (GHS) between 2008 and 2013.

Patient Characteristics Associated With Severe Hypoglycemia in a Type 2 Diabetes Cohort in a Large, Integrated Health Care System From 2006 to 2015.

Objective: To identify severe hypoglycemia events, defined as emergency department visits or hospitalizations for hypoglycemia, in patients with type 2 diabetes receiving care in a large health system and to identify patient characteristics associated with severe hypoglycemia events.

Research Design And Methods: This was a retrospective cohort study from January 2006 to December 2015 using the electronic medical record in the Cleveland Clinic Health System (CCHS). Participants included 50,439 patients with type 2 diabetes receiving care in the CCHS.

Ten-Year Outcomes and Risk Factors After Anterior Cruciate Ligament Reconstruction: A MOON Longitudinal Prospective Cohort Study.

Background: The long-term prognosis and risk factors for quality of life and disability after anterior cruciate ligament (ACL) reconstruction remain unknown. Hypothesis/Purpose: Our objective was to identify patient-reported outcomes and patient-specific risk factors from a large prospective cohort at a minimum 10-year follow-up after ACL reconstruction. We hypothesized that meniscus and articular cartilage injuries, revision ACL reconstruction, subsequent knee surgery, and certain demographic characteristics would be significant risk factors for inferior outcomes at 10 years.

Next-generation prostate cancer risk calculator for primary care physicians.

Introduction: Current prostate cancer risk calculators are limited in impact because only a probability of having prostate cancer is provided. We developed the next generation of prostate cancer risk calculator that incorporates life expectancy in order to better evaluate prostate cancer risk in context to a patient's age and comorbidity.

Methods: We combined two cohorts to develop the new risk calculator.

Predicting 30-Day All-Cause Readmission Risk for Subjects Admitted With Pneumonia at the Point of Care.

Background: The pneumonia 30-d readmission rate has been endorsed by the National Quality Forum as a quality metric. Hospital readmissions can potentially be lowered by improving in-hospital care, transitions of care, and post-discharge disease management programs. The purpose of this study was to create an accurate prediction model for determining the risk of 30-d readmission at the point of discharge.

Predicting risk of pelvic floor disorders 12 and 20 years after delivery.

Background: Little progress has been made in the prevention of pelvic floor disorders, despite their significant health and economic impact. The identification of women who are at risk remains a key element in targeting prevention and planning health resource allocation strategies. Although events around the time of childbirth are recognized clinically as important predictors, it is difficult to counsel women and to intervene around the time of childbirth because of an inability to convey a patient's risk accurately in the presence of multiple risk factors and the long time lapse, which is often decades, between obstetric events and the onset of pelvic floor disorders later in life.

Effect of glycemic control on the Diabetes Complications Severity Index score and development of complications in people with newly diagnosed type 2 diabetes.

Background: The aim of the present study was to assess the longitudinal accumulation of diabetes-related complications and the effect of glycemic control on the Diabetes Complications Severity Index (DCSI) score in people with newly diagnosed type 2 diabetes (T2D).

Methods: A retrospective cohort study was conducted using electronic health records from a large integrated healthcare system. People with newly diagnosed T2D were identified between 2005 and 2016 and stratified by initial HbA1c category (<7%, <8%, ≥8%).

A model to predict risk of postpartum infection after Caesarean delivery.

Purpose: The purpose of this study is to build and validate a statistical model to predict infection after caesarean delivery (CD).

Methods: Patient and surgical variables within 30 d of CD were collected on 2419 women. Postpartum infection included surgical site infection, urinary tract infection, endomyometritis and pneumonia.

Prescriber Compliance With Liver Monitoring Guidelines for Pazopanib in the Postapproval Setting: Results From a Distributed Research Network.

Objectives: Pazopanib received US Food and Drug Administration approval in 2009 for advanced renal cell carcinoma. During clinical development, liver chemistry abnormalities and adverse hepatic events were observed, leading to a boxed warning for hepatotoxicity and detailed label prescriber guidelines for liver monitoring. As part of postapproval regulatory commitments, a cohort study was conducted to assess prescriber compliance with liver monitoring guidelines.

Association of glucagon-like peptide-1 receptor agonist use and rates of acute myocardial infarction, stroke and overall mortality in patients with type 2 diabetes mellitus in a large integrated health system.

Aims: To assess the potential impact of glucagon-like peptide-1 receptor agonist (GLP-1RA) exposure on cardiovascular disease (CVD) and mortality outcomes in patients with type 2 diabetes (T2D), using a large retrospective cohort.

Research Design And Methods: Patients who had T2D between 2005 and 2014 (N = 105 862) were identified from the electronic health record system at Cleveland Clinic using a validated electronic phenotype. A time-dependent, Cox, multiple regression analysis was used to assess the association between GLP-1RA exposure and risk of acute myocardial infarction (AMI), stroke/cerebrovascular accident (CVA), and overall mortality, as well as the composite of all three outcomes.

A model to predict risk of blood transfusion after gynecologic surgery.

Background: A model that predicts a patient's risk of receiving a blood transfusion may facilitate selective preoperative testing and more efficient perioperative blood management utilization.

Objective: We sought to construct and validate a model that predicts a patient's risk of receiving a blood transfusion after gynecologic surgery.

Study Design: In all, 18,319 women who underwent gynecologic surgery at 10 institutions in a single health system by 116 surgeons from January 2010 through June 2014 were analyzed.

Intensification of Diabetes Therapy and Time Until A1C Goal Attainment Among Patients With Newly Diagnosed Type 2 Diabetes Who Fail Metformin Monotherapy Within a Large Integrated Health System.

Objective: "Clinical inertia" has been used to describe the delay in the intensification of type 2 diabetes treatment among patients with poor glycemic control. Previous studies may have exaggerated the prevalence of clinical inertia by failing to adequately monitor drug dose changes and nonmedication interventions. This project evaluated the intensification of diabetes therapy and hemoglobin A1c (A1C) goal attainment among patients with newly diagnosed type 2 diabetes when metformin monotherapy failed.